A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Launched by ELI LILLY AND COMPANY · Jan 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LY3541860 for adults with relapsing forms of multiple sclerosis (MS), a condition where symptoms can get better and worse over time. The main goal of the study is to see if this treatment is safe and effective for people who have had recent relapses or specific changes in their brain scans related to MS. The study will last about 9 months, with an additional 6 months of follow-up to monitor participants’ health.

To be eligible for this trial, participants must be between 18 and 65 years old and have a documented history of relapsing MS, meaning they have experienced at least one relapse in the past year or two relapses in the last two years. They should also have a certain level of disability that isn’t too severe. Participants can expect regular check-ups and assessments to track their progress throughout the study. It's important to note that people with other forms of MS or certain serious health conditions may not be able to take part in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must meet criteria for relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis based on the 2017 revision of the McDonald diagnostic criteria (Thompson et al. 2018) with a relapsing course (RMS) activity according to Klineova and Lublin 2018.
• * Participants must have 1 of these:
• • at least 1 documented relapse within the previous year
• • at least 2 documented relapses within the previous 2 years, or
• • at least 1 active GdE brain lesion on an MRI scan in the past 180 days prior to screening.
• • Have an Expanded Disability Status Scale (EDSS) score of less than or equal to (≤) 5.5 at screening and randomization.
• Exclusion Criteria:
• * Have had a diagnosis of:
• • primary progressive multiple sclerosis (MS) according to the 2017 revision of McDonald diagnostic criteria (Thompson et al. 2018), or
• • nonactive secondary progressive MS ( Klineova and Lublin 2018).
• • Meet criteria for neuromyelitis optica spectrum disorder (Wingerchuk and Lucchinetti 2022).
• • Have a history of clinically significant central nervous system (CNS) disease.
• • Have had a confirmed relapse with systemic corticosteroid administration \<30 days prior to randomization.
• • Have more than 20 active GdE brain lesions on screening MRI scan.
• • Have received any of these medications or treatments.
• • Have a current or recent acute, active infection.
• • Have current serious or unstable illnesses.
• • Have any other clinically important abnormality at screening or baseline.